Hand and Foot SyndromeNCT00767689
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
A study testing Vitamin B 6 in people with Hand and Foot Syndrome, run by Cook County Health at 1 site in United States.
Trial summary
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hand and Foot Syndrome
- What is being tested?
- Vitamin B 6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2006to 17 Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any adult patient starting capecitabine-containing chemotherapy
- Has never had capecitabine before
- Performance status 0-2 using the ECOG classification
- Life expectancy more than 6 months
- Agreed to stop any vitamin supplements, apart from vitamin D.
- Liver function studies including AST/ALT within 3x upper limit of normal
- Signed informed consent must be obtained from participating individuals
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
John H stroger Jr hospital of cook county
Chicago, Illinois, 60612
About this study
Official title: A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.
Read the detailed description
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.
- Conditions
- Hand and Foot Syndrome
- Being tested
- Vitamin B 6, placebo
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B 6Drug
Also called pyridoxine
vitamin b6 100 mg po daily
placeboDrug
placebo is given in the placebo arm
| Study group | Role | What they receive |
|---|---|---|
| vitamin B6 | Experimental | patient receiving xeloda and vitamin B6 Receives: Drug: Vitamin B 6 |
| 2 placebo | Placebo comparator | patient receiving xeloda and placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hand-Foot Syndrome (HFS)
Incidence of HFS based on CTCTAE adverse event table
Measured: 1 year
Secondary outcomes (1)
Grade of Hand-Foot Syndrome (HFS)
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study start21 Mar 2006
- Primary completion18 Mar 2009
- Study completion17 Mar 2010
Why it stopped: incomplete enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand and Foot SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health
- Investigators
- Thomas Lad, MD, Study director, Cook County Health Oncology NCORPSusan McDunn, MD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767689
- Sponsor's protocol ID
- 08-069
- Status last verified
- Jun 2023
- First submitted
- 6 Oct 2008
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
- ClinicalTrials.gov ID
- NCT00767689
- Acronym / sponsor ID
- 08-069
- Conditions
- Hand and Foot Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: incomplete enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 21 Mar 2006 (actual)
- Primary completion
- 18 Mar 2009 (actual)
- Study completion
- 17 Mar 2010 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.
Detailed description
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin B6 | Experimental | Drug: Vitamin B 6patient receiving xeloda and vitamin B6 |
| 2 placebo | Placebo comparator | Drug: placebopatient receiving xeloda and placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Any adult patient starting capecitabine-containing chemotherapy
- Has never had capecitabine before
- Performance status 0-2 using the ECOG classification
- Life expectancy more than 6 months
- Agreed to stop any vitamin supplements, apart from vitamin D.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B 6Also: pyridoxinevitamin b6 100 mg po daily | Drug | vitamin B6 |
| placeboplacebo is given in the placebo arm | Drug | 2 placebo |
Primary outcome
Incidence of Hand-Foot Syndrome (HFS)
Time frame: 1 year
Incidence of HFS based on CTCTAE adverse event table
1 secondary outcome
Grade of Hand-Foot Syndrome (HFS)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: incomplete enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Related trials for Hand and Foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
RecruitingPhase 2
SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
Not yet recruiting
Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
TAR-0520 Gel in Hand and Foot Syndrome
Hand and Foot Syndrome
Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
Hand-foot Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lad, MD study director
Cook County Health Oncology NCORP
Susan McDunn, MD principal investigator
Cook County Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B 6 in people with Hand and Foot Syndrome, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: incomplete enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hand-Foot Syndrome (HFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.